Intraveous Catheter Insertion Device

ABSTRACT

A method for treating a patient using a catheter insertion device. The catheter insertion device includes a housing, a needle, a catheter, a guidewire, and a thumbwheel. The needle extends through the catheter such that a distal end of the needle extends distal of a distal end of the catheter. The guidewire is coupled to the thumbwheel such that rotation of the thumbwheel advances a distal end of the guidewire through a lumen of the needle. The method includes holding the catheter insertion device, inserting the distal end of the needle and catheter into a blood vessel, rotating the thumbwheel to advance the distal end of the guidewire out of the lumen of the needle into the blood vessel, moving the catheter over the guidewire in the blood vessel, and removing the needle and the guidewire from the catheter.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/292,076, filed Mar. 4, 2019, which is a continuation of U.S. patentapplication Ser. No. 14/866,441, filed Sep. 25, 2015, now U.S. Pat. No.10,220,191, which is a continuation of U.S. patent application Ser. No.11/577,491, filed Aug. 20, 2008, now U.S. Pat. No. 9,162,037, which is aU.S. national stage application under 35 U.S.C. § 371 of InternationalApplication No. PCT/US2006/026671, filed Jul. 6, 2006, which claims thebenefit of priority to U.S. Provisional Application No. 60/697,333,filed Jul. 6, 2005, each of which is incorporated by reference in itsentirety into this application.

FIELD OF THE INVENTION

The present invention relates to devices and methods for insertion andplacement of an intravenous catheter into a vein or artery of a patient.The devices and methods of the invention facilitate safe placement ofthe catheter into the patient's vein or artery, which is of particularimportance in the case of small, tortuous, collapsed, fragile, and/ordifficult to locate vessels. The devices and methods also provideprotection against accidental punctures and/or contamination by theneedle after placement of the intravenous catheter.

BACKGROUND OF THE INVENTION

The following patents describe prior intravenous catheter insertiondevices and/or safety devices for syringes and needles.

-   Haining—EP00515710A1 Intravenous catheter and insertion device-   Haining—EP00515710B1 Intravenous catheter and insertion device-   Haining—U.S. Pat. No. 5,019,049 Intravenous catheter and insertion    device-   Haining—U.S. Pat. No. 5,176,650 Intravenous catheter and insertion    device-   Chang—EP00567321A2 Intravenous catheter with needle guard-   Mahurkar—EP00652020B1 Retractable hypodermic needle assembly-   Mahurkar—EP00910988A1 Blood sample collection assembly-   Mahurkar—U.S. Pat. No. 5,891,105 Hypodermic needle assembly-   DeWitt—U.S. Pat. No. 3,572,334 Intravenous catheter placement unit-   van Heugten—EP00750916A2 Protective needle cover containment-   Botich—EP00942761B1 Medical device with retractable needle-   Botich—EP01075850B1 Apparatus for intravenous catheter insertion-   Botich et al—U.S. Pat. No. 5,800,395 Medical device with retractable    needle-   Botich et al—U.S. Pat. No. 6,436,070 Catheter insertion device with    retractable needle-   Botich et al—U.S. 2003/0060760 Catheter insertion device with    retractable needle-   Botich et al—WO 2000/012160 A1 Fluid infusion device with    retractable needle-   Botich—WO 2009/632981 Safety stylet for intravenous catheter    insertion-   Botich—WO 2009/824494 Medical device with retractable needle-   Shue—EP01457229A1 Intravenous catheter inserting device-   Shue—U.S. Pat. No. 6,921,386 Intravenous catheter inserting device-   Harautuneian—U.S. Pat. No. 3,592,192 Intravenous catheter apparatus    with catheter telescoped on outside of puncturing cannula-   Harautuneian—U.S. Pat. No. 3,610,240 Intravenous catheter apparatus    with catheter telescoped inside puncturing cannula-   Poncy et al—U.S. Pat. No. 4,037,600 Catheter placement system-   Hession—U.S. Pat. No. 4,292,970 Apparatus for intravenous catheter    starter-   McDonald—U.S. Pat. No. 4,834,718 Safety needle apparatus-   McDonald—U.S. Pat. No. 4,944,725 Safety needle apparatus-   Vining et al—U.S. Pat. No. 4,909,793 Intravenous catheter apparatus    with retractable stylet-   Carrell et al—U.S. Pat. No. 4,944,728 Intravenous catheter placement    device-   Kaufman—U.S. Pat. No. 4,966,589 Intravenous catheter placement    device-   Shields—U.S. Pat. No. 5,007,901 Intravenous catheter insertion    device-   Haughton et al—U.S. Pat. No. 5,562,629 Catheter placement system    utilizing a handle, a sharp, and a releasable retainer mechanism    providing retraction of the sharp upon disengagement of the catheter    from the handle-   Flumene et al—U.S. Pat. No. 5,562,634 Intravenous catheter with    automatically retracting needle-guide-   Isaacson—U.S. Pat. No. 5,573,510 Safety intravenous catheter    assembly with automatically retractable needle-   Isaacson—U.S. Pat. No. 6,056,726 Self-contained safety intravenous    catheter insertion device-   Isaacson—WO 2009/523003 Self-contained safety intravenous catheter    insertion device-   Huang—U.S. Pat. No. 5,891,098 Safety intravenous catheter-   Bhitiyakul—U.S. Pat. No. 5,941,854 Intravenous catheter-   Dysarz—U.S. Pat. No. 5,997,507 Biased spring hard needle retractable    IV catheter-   Dysarz—U.S. Pat. No. 6,193,690 Inclined plane latching device for an    IV catheter-   Greene et al—U.S. Pat. No. 6,221,047 Safety intravenous catheter    assembly and method for use with a needle-   Greene et al—U.S. Pat. No. 6,689,102 Safety intravenous catheter    assembly-   Greene et al—U.S. Pat. No. 6,695,814 Safety intravenous catheter    assembly and method for use with a needle-   Greene et al—U.S. Pat. No. 6,695,814 Safety intravenous catheter    assembly and method for use with a needle-   Greene et al—U.S. Pat. No. 6,689,102 Safety intravenous catheter    assembly-   Greene et al—WO 2000/006226 Safety intravenous catheter assembly and    method for use with a needle-   Chang—U.S. Pat. No. 6,322,537 Safety intravenous catheter-   Pressly, Sr. et al—U.S. Pat. No. 6,620,136 Retractable IV catheter    placement device-   Pressly, Sr. et al—WO 2000/047256 Retractable IV catheter placement    device-   Hoffman et al—U.S. Pat. No. 6,730,062 Safety catheter with    non-removable retractable needle-   Hoffman et al—U.S. Pat. No. 6,730,062 Safety catheter with    non-removable retractable needle-   Brustowicz—U.S. 2004/0267204 On-demand needle retaining and locking    mechanism for use in intravenous catheter assemblies-   Garcia Andreo—WO 2003/043686 Flow regulating/autovalve intravenous    catheter-   Sircom—WO 2009/222344 Needle guard for intravenous catheter    placement-   Ogle—WO 2009/519193 Retractable venipuncture catheter needle and    receptacle-   Rohrbough et al—WO2009/705912 Retractable venipuncture catheter    needle and receptacle-   Hwang—WO 2009/721458 Intravenous catheter with flexible extender and    protector against needle tip

SUMMARY OF THE INVENTION

In one aspect, the present invention takes the form of an intravenouscatheter insertion device that provides coordinated movement of anaccess needle, an intravenous catheter and a safety guidewire. Thedevice holds the access needle and the intravenous catheter in a coaxialarrangement for puncturing a vein or other target vessel. A bloodflashback chamber provides a visual indication that the tip of theneedle is in the lumen of the vein. Upon vein puncture by the accessneedle, a flexible safety guidewire is advanced through the accessneedle into the lumen of the vein using an actuation member located onthe exterior of the device. With the flexible safety guidewire deployedwithin the lumen of the vein, the access needle and the intravenouscatheter can be safely advanced into the vein until the tip of theintravenous catheter is also within the lumen of the vein.Alternatively, the intravenous catheter can be advanced separately whileholding the access needle stationary. Then, the actuation member isactuated to simultaneously withdraw the access needle and the safetyguidewire. Preferably, the access needle and the safety guidewire arewithdrawn automatically by the action of a spring or other biasingmember, leaving only the intravenous catheter in the vein. Once theaccess needle and the safety guidewire have been withdrawn, theintravenous catheter can be disconnected from the insertion device andconnected to a source of intravenous fluid, medication, etc.

In another aspect, the present invention provides an improved method forinsertion and placement of an intravenous catheter. The method includesthe steps of: puncturing a vein or other target vessel with an accessneedle arranged coaxially with an intravenous catheter; verifying thelocation of the access needle tip in the lumen of the vein; advancing asafety guidewire through the access needle into the lumen of the vein,advancing the tip of the intravenous catheter into the vein; andsimultaneously withdrawing the access needle and the safety guidewirefrom the intravenous catheter and from the patient.

Although the invention is described in relation to insertion of anintravenous catheter, the apparatus and methods described herein couldreadily be adapted for insertion of any catheter or similar device intoa vein, artery or other internal body structure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an exploded view of an intravenous catheter insertiondevice according to the present invention.

FIG. 2 shows an assembly drawing of the intravenous catheter insertiondevice in an undeployed state, ready for use.

FIG. 3 shows a phantom view of the intravenous catheter insertion devicewith the safety guidewire advanced.

FIGS. 4A and 4B are detail drawings of a safety guidewire for use withthe intravenous catheter insertion device.

FIGS. 5A, 5B and 5C are detail drawings of another safety guidewire foruse with the intravenous catheter insertion device.

FIG. 6 shows another embodiment of an intravenous catheter insertiondevice according to the present invention.

FIGS. 7-9 illustrate a method of intravenous catheter insertionaccording to the present invention.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 shows an exploded view of one embodiment of an intravenouscatheter insertion device 20 according to the present invention. FIG. 2shows an assembly drawing of the intravenous catheter insertion device20 in an undeployed state, ready for use. FIG. 3 shows a phantom view ofthe intravenous catheter insertion device 20 with the safety guidewireadvanced.

The intravenous catheter insertion device 20 includes an outer housing1. In the example shown, the outer housing 1 is in the form of anelongated hollow cylinder. Other shapes, including an ergonomic handleshape, are possible. The outer housing 1 may be formed from any materialsuited for use in medical applications. In one embodiment, the outerhousing 1 is preferably molded from a rigid, transparent medical gradeplastic. Alternatively, the outer housing 1 may be machined from anextruded plastic tube. There is an elongated slot 14 in the outerhousing 1 approximately parallel with the axis of the outer housing 1.The slot 14 is sized to accommodate the dowel pin 10 or provide aconnection point to the slider 4 to move the slider along the interiorof the outer housing 1. The distal end of the slot 14 widens into atriangular cutout 15, as seen in FIGS. 2 and 3. Other shapes of the cutout 15 are possible.

A front plug 2 is sized to fit onto the distal end of the outer housing1. The front plug 2 is preferably molded, or alternatively machined,from a rigid, transparent medical grade plastic. The front plug 2 isglued, pinned, welded or otherwise fastened to the distal end of theouter housing 1. The distal end of the front plug 2 includes a luer slipfitting 16 or the like. There is a shoulder or flange 17 to mate withthe distal end of the outer housing 1. The proximal end of the frontplug 2 has an interlocking member 18 that interlocks with a matinginterlocking member 19 on the needle carrier 6. In the example shown,the interlocking member 18 is a tab that interlocks with a correspondingspiral pawl or quarter-turn thread interlocking member 19 on the needlecarrier 6. Other geometries for the interlocking members 18, 19 arepossible.

In the exemplary embodiment of FIGS. 1-3, the geometry of the slot 14and the triangular cutout 15 are chosen to operate cooperatively withthe rotating interlocking members 18, 19. The slot 14 allows theactuator handle 9 to move in a longitudinal direction with respect tothe outer housing 1 to advance the safety guidewire 11 distally, whileat the same time restricting lateral motion to avoid prematurewithdrawal of the access needle 8 and the safety guidewire 11. Thewidening of the slot 14 at the distal end into a triangular cutout 15allows the actuator handle 9 to be selectively rotated laterally todisengage the rotating interlocking members 18, 19 and release thebiasing member 12 to withdrawal of the access needle 8 and the safetyguidewire 11 after the safety guidewire 11 has been fully advanced. If adifferent geometry or different release mechanism is used in place ofthe rotating interlocking members 18, 19, the geometry of the slot 14and the triangular cutout 15 may have to be modified to accommodate therelease mechanism.

The needle carrier 6 is shaped and sized to fit inside the outer housing1. In the embodiment shown in FIGS. 1-3, the needle carrier 6 has acylindrical shape that is sized to have a sliding fit within thecylindrical outer housing 1. Other shapes are possible and generally theneedle carrier 6 will be shaped to be compatible with the interiorgeometry of the outer housing 1. The needle carrier 6 is preferablymolded, or alternatively machined, from any material suited for use in amedical environment. In one embodiment, the needle carrier 6 is formedfrom a rigid, transparent medical grade plastic. A tubular access needle8 with a sharpened beveled distal end is attached to a needle carriernose 5, which is in turn attached to the needle carrier 6. The accessneedle 8 is preferably made from stainless steel hypodermic tubing. Asmall cavity or blood flashback chamber that communicates with the lumenof the access needle 8 is positioned within the needle carrier 6,between the needle carrier nose 5 and the needle carrier 6. As mentionedabove, the distal end of the needle carrier 6 has an interlocking member19 that is configured to interlock with a mating interlocking member 18on the proximal end of the front plug 2. In one exemplary embodiment,the interlocking members 18, 19 are adapted to lock and unlock byrotation of the needle carrier 6 with respect to the front plug 2. Theinterlocking members 18, 19 may also lock and unlock using abayonet-type fitting. In the example shown, the interlocking member is aspiral pawl interlocking member 19 that interlocks with a correspondingtab interlocking member 18 on the front plug 2. In one embodiment, theinterlocking members lock and/or unlock using less than one revolutionof the needle carrier 6. In another embodiment, the interlocking memberslock and/or unlock using less than one half a revolution of the needlecarrier 6. In still another alternative embodiment, the interlockingmembers lock and/or unlock using less than one quarter revolution of theneedle carrier 6. Other geometries for the interlocking members arepossible.

A biasing member 12 is configured to fit between the needle carrier 6and the front plug 2 to urge them apart. The force of the biasing member12 is resisted by the interlocking members 18, 19 when the needlecarrier 6 and the front plug 2 are locked together. In one embodiment,the biasing member 12 is a spring. Note that in FIG. 1 the biasingmember or compression spring 12 is shown in a compressed condition as itwould be in the assembled intravenous catheter insertion device 20 in anundeployed condition.

In an alternate embodiment, the interlocking members 18, 19 may bereplaced by two members that are bonded together with a breakable bondor a single member with a breakable link. The member or members would beconfigured to constrain the biasing member 12 until it is desired towithdraw the access needle 8 and safety guidewire 11, at which time, theactuator would break the bond or link to release the biasing member 12.This configuration would make the device 20 more resistant toremanufacturing or reuse.

A tubular intravenous catheter 13, such as an ANGIOCATH, fits coaxiallyaround the access needle 8. Preferably, the intravenous catheter 13 hasa close fit with the access needle 8 and a tapered distal end tominimize any step between the access needle 8 and the intravenouscatheter 13 as they are inserted through the wall of a vein. There is aluer fitting 27 or the like on the proximal end of the intravenouscatheter 13 that fits onto the luer slip fitting 16 on the distal end ofthe front plug 2 with a slight interference fit to hold the intravenouscatheter 13 in place. Alternative configurations of the device may use aluer lock or other locking mechanism to attach the intravenous catheter13 to the front plug 2.

A slider 4 is generally cylindrical in shape and sized for a sliding fitinside the cylindrical outer housing 1. Other shapes for the slider 4are possible depending on the interior geometry of the outer housing 1.The slider 4 is preferably molded, or alternatively machined, from anysuitable medical grade material. For example, the slider may be formedfrom a rigid medical grade plastic. A handle 9 or actuating memberattaches to the slider 4 with a dowel pin 10 or other attachment memberthat extends through the slot 14 in the outer housing 1. The slider 4fits into the outer housing 1 proximal to the needle carrier 6. A pin 25extends from the distal surface of the slider 4 and is configured toreversibly engage with a hole, step, boss or similar mating feature 26on the proximal end of the needle carrier 6. When pin 25 is coupled tothe mating feature 26 during the appropriate step of the intravenouscatheter insertion and placement procedure, rotation of the slider 4 istransferred to the needle carrier 6 to facilitate engagement and ordisengagement of the interlocking members 18, 19. Pin 25 and feature 26are merely illustrative. Pin 25 may be replaced with a female featurewhile a mating male feature may be placed on the proximal face of theneedle carrier 6. Additionally, the mating features 25, 26 are alignedrelative to the elongated slot and the sliding movement of the slider 4so that distal movement of the slider 4 will engage the mating features25, 26. Optionally, the device 20 may be configured so that theconnection between the slider 4 and needle carrier 6 happensirreversibly when the device 20 is actuated.

As best seen in FIG. 3, a safety guidewire 11 is attached, directly orindirectly, to the slider 4 so that it can be advanced and retractedwith the handle 9 attached to the slider 4. In a preferred embodiment,the safety guidewire 11 is constructed of superelastic Nickel-Titaniumalloy (Nitinol) wire. Because this type of wire is extremely flexible,it is advantageous to have the safety guidewire 11 enclosed along mostof its length to avoid bowing or buckling while advancing the safetyguidewire 11. For this reason, the example shown includes a supporttubing 7 that is attached to the proximal end of the needle carrier 6.The safety guidewire 11 extends through the internal lumen of a sheathtubing 3 and the proximal end of the safety guidewire 11 is attached atthe proximal end of the sheath tubing 3. The distal end of the sheathtubing 3 is in turn attached to the slider 4, indirectly attaching thesafety guidewire 11 to the slider 4. The support tubing 7 has a slidingfit inside the sheath tubing 3 so that the two parts telescope togetheras the slider 4 is advanced in the distal direction. The telescopingaction of the support tubing 7 and the sheath tubing 3 provides avariable length support for the proximal portion of the safety guidewire11 to prevent bowing or buckling of the safety guidewire 11 as it isadvanced. The support tubing 7 and the sheath tubing 3 are preferablymade from stainless steel hypodermic tubing, however any suitablemedical grade plastic material may also be used. In other embodiments,such as those using a larger diameter or stiffer guidewire, thetelescoping support tubes may not be necessary, and the proximal end ofthe safety guidewire 11 may be attached directly to the slider 4.

FIGS. 4A and 4B are detail drawings of a safety guidewire 11 for usewith the intravenous catheter insertion device 20. The safety guidewire11 is preferably constructed of superelastic Nickel-Titanium alloy wireapproximately 0.004-0.012 inches in diameter and most preferablyapproximately 0.008 inches in diameter. As shown in FIG. 4B, the distalend of the safety guidewire 11 is preformed into a tightly wound spiralwith an outer diameter smaller than the internal diameter of the targetvessel into which it will be inserted. The spiral tip acts as a safetybumper on the guidewire to avoid puncturing or damaging the inside oftarget vessels. The coiled guidewire tip is particularly useful inprotecting fragile or delicate veins. Due to the extreme flexibility ofthe Nickel-Titanium alloy wire, the spiral distal curve can straightenout when the safety guidewire 11 is withdrawn into the access needle 8and completely recover into the spiral configuration without plasticdeformation when the safety guidewire 11 is advanced out of the accessneedle 8. In the example shown, the distal end of the safety guidewire11 has a first, small diameter coil of approximately 0.167 inches indiameter for approximately 0.75 revolutions and a second, largerdiameter coil of approximately 0.175 inches in diameter forapproximately 1 revolution. The first and second coils are preferablyapproximately coplanar with one another and preferably approximatelycoplanar with the straight proximal portion of the guidewire 11 also.Other configurations of the safety guidewire 11 may include:multi-planar, single coil, full radius on the end, and/or a balled endwith diameter less than the diameter of the needle.

FIGS. 5A, 5B and 5C are detail drawings of another safety guidewire 11for use with the intravenous catheter insertion device 20. In thisembodiment, a distal portion of an approximately 0.008 inch diameterNickel-Titanium alloy wire has been tapered by grinding, stretching,etc., to a diameter of approximately 0.004 inches to make it moreflexible and to allow it to be formed into a smaller diameter spiral foruse in smaller diameter veins. The spiral curve of the guidewire tipwill preferably have an outer diameter smaller than the inner diameterof the target vessel. In the example shown, the spiral curve has afirst, small diameter coil of approximately 0.034 inches in diameter forapproximately 0.75 revolutions and a second, larger diameter coil ofapproximately 0.059 inches in diameter for approximately 1 revolution.The first and second coils are preferably approximately coplanar withone another and preferably approximately coplanar with the straightproximal portion of the guidewire 11 also.

Other sizes and geometries of safety guidewire 11 are also possible.

To assemble the intravenous catheter insertion device 20 shown in FIGS.1-3, the access needle 8 is bonded flush with the proximal face of theneedle carrier nose 5, which is in turn bonded into the needle carrier6. The support tubing 3 is placed into the distal hole in the needlecarrier 6, and bonded flush with the proximal face of the bloodflashback chamber. The formed safety guidewire 11 is advanced throughthe lumen of the access needle 8 and support tubing 7 until the coiledsection of the safety guidewire 11 meets the access needle 8 bevel. Thesheath tubing 3 is slid through the slider 4, and bonded when flush withthe distal face. The assembly of the sheath tubing 3 and slider 4 areadvanced over the safety guidewire 11. When the safety guidewire 11 isflush with the proximal end of the sheath tubing 3, the two are bonded.The spring 12 is compressed on the needle carrier nose 5, advanced intothe front plug 2 and the interlocking members 18, 19 of the front plug 2and needle carrier 6 are engaged. This assembly of components is placedinto the outer housing 1 and advanced until the front plug 2 is flushwith the outer housing 1, and then the front plug 2 is rotated forproper alignment. The front plug 2 is then bonded to the outer housing1. The dowel pin 10 and handle 9 are pressed together with the slider 4.The handle 9 is slid proximally to withdraw the safety guidewire 11 intothe access needle 8, thereby straightening out the spiral distal curve.An intravenous catheter 13 is then mounted coaxially around the accessneedle 8. Optionally, the intravenous catheter 13 insertion device maybe provided with a needle cover or other protective packaging. Theassembled intravenous catheter insertion device 20, including theintravenous catheter 13, is then packaged, labeled and sterilized.

The preceding assembly description is provided to illustrate one exampleof a process for manufacturing an embodiment of the intravenous catheterinsertion device 20 and also so that the interrelationship of thevarious components will be understood. Modifications and variations ofthis description are expected depending upon specific selected assemblyor manufacturing techniques. For example, components that are bonded maybe redesigned to be formed from a single integrated piece and the like.The manufacturing process can be modified and adapted for assemblingother embodiments of the intravenous catheter insertion device 20.

FIG. 6 shows an interior view of another embodiment of an intravenouscatheter insertion device 20 according to the present invention. Thisembodiment is similar in many respects to the intravenous catheterinsertion device 20 of FIGS. 1-3. The intravenous catheter insertiondevice 20 includes an outer housing 1, front plug 2, which mayoptionally be molded integrally with the outer housing 1, a needle 8attached to a needle carrier 6, a safety guidewire 11, spring 12 andintravenous catheter 13. However, the functions of the handle 9 and theslider 4 have been replaced by a thumbwheel 21 that engages a pair offriction wheels 22, 23, which are in contact with the safety guidewire11. Likewise, the functions of the sheath tubing 3 and the supporttubing 7 have been replaced by a guidewire spool 24. These featuresallow the intravenous catheter insertion device 20 to be constructed ina more compact configuration. In use, the safety guidewire 11 isadvanced by turning the thumbwheel 21. A lateral movement of thethumbwheel 21 disengages the needle carrier 6 from the front plug 2,allowing the biasing member 12 to expand, thereby retracting the needle8 and the safety guidewire 11 into the outer housing 1. Alternatively, aseparate button, lever or other actuation member can be provided toactuate the withdrawal of the needle 8 and the safety guidewire 11. Theguidewire spool 24 may optionally include a rotary spring or similarmechanism (not shown) to assist in the retraction of the safetyguidewire 11 into the outer housing 1.

FIGS. 7-9 illustrate a method of inserting an intravenous catheter usingan intravenous catheter insertion device 20, such as those described inFIGS. 1-3 or FIG. 6. The intravenous catheter insertion device 20 is asingle-use, non-reusable device supplied to the physician or medicalpractitioner sterile in a ready-to-use, undeployed condition as shown inFIG. 2. In use, the physician uses the outer housing 1 as a handle tomanipulate the intravenous catheter insertion device 20. With the devicein the undeployed condition, the access needle 8 is used to puncture avein, as shown in FIG. 7. When venous blood is observed in the bloodflashback chamber, the distal tip of the access needle 8 is the lumen ofthe vein. The physician can then advance the handle 9 in the distaldirection to extend the safety guidewire 11 out of the access needle 8into the lumen of the vein. The distal portion of the safety guidewire11 assumes its spiral configuration to act as a safety bumper to preventaccidental puncture of the far wall of the vein or other damage to thevein. With the safety guidewire 11 thus deployed, the physician cansafely continue advancing the intravenous catheter insertion device 20until the distal tip of the intravenous catheter 13 is in the lumen ofthe vein. Once the intravenous catheter 13 is inserted far enough intothe vein, the physician rotates the handle 9 that rotates the slider 4,which in turn rotates the needle carrier 6 and disengages theinterlocking member 18 of the needle carrier 6 from the matinginterlocking member 19 on the front plug 2. (In the exemplary embodimentdescribed above, the handle moves in a counterclockwise direction asallowed by the triangular cutout 15 at the distal end of the slot 14 inthe outer housing 1. Additional structural features of the actuatormechanism are shown in more detail in FIGS. 1-3.) When the handle 9 isreleased, the biasing element (here a compression spring 12) urges theneedle carrier 6 and the slider 4 in the proximal direction, thussimultaneously withdrawing the access needle 8 and the safety guidewire11 into the outer housing 1, leaving only the intravenous catheter 13 inthe lumen of the vein. FIG. 8 shows the access needle 8 and the safetyguidewire 11 withdrawing into the outer housing 1. The shape of thetriangular cutout 15 allows the handle 9 to make a smooth transitioninto the elongated slot 14 as it moves proximally under the influence ofthe biasing element 12. Finally, the intravenous catheter 13 isdisengaged from the luer slip 16 fitting on the distal end of the frontplug 2, as shown in FIG. 9, and a source of intravenous fluid, a syringeor other device is attached to the luer fitting 27 of the intravenouscatheter 13.

While it is desirable for the intravenous catheter insertion device 20to withdraw the access needle 8 and the safety guidewire 11simultaneously, the actuator mechanism could also be modified towithdraw the access needle 8 and the safety guidewire 11 sequentially.For example, the actuator mechanism could withdraw the access needle 8first and then, after a slight delay, withdraw the safety guidewire 11.

Alternatively, the actuator mechanism could be modified to require twoseparate motions of one actuator member or selective movements of twoseparate actuator members to withdraw the access needle 8 and the safetyguidewire 11 selectively.

In an alternative embodiment of the intravenous catheter insertiondevice 20, the compression spring 12 may be omitted from the actuatormechanism, thus allowing the access needle 8 and the safety guidewire 11to be withdrawn manually using the handle 9. Once the intravenouscatheter 13 has been inserted into the patient's vein, the handle 9 isrotated laterally to disengage the needle carrier 6 from the front plug2, then the handle 9 is moved proximally along the slot 14 to withdrawthe access needle 8 and the safety guidewire 11 into the outer housing1.

While the present invention has been described herein with respect tothe exemplary embodiments and the best mode for practicing theinvention, it will be apparent to one of ordinary skill in the art thatmany modifications, improvements and subcombinations of the variousembodiments, adaptations and variations can be made to the inventionwithout departing from the spirit and scope thereof. For example, alldimensions and materials included in the specification or drawings areintended only as examples of presently preferred embodiments and are notintended to limit the scope of the invention.

What is claimed is:
 1. A method for treating a patient, comprising:holding a catheter insertion device comprising: a housing; a catheterincluding a catheter hub; a needle extending through the catheter, theneedle having a distal end extending distal of a distal end of thecatheter; and a guidewire coupled to a thumbwheel, the thumbwheelpositioned at a front end of the housing through an opening in thehousing, wherein rotation of the thumbwheel advances a distal end of theguidewire through a lumen of the needle; inserting the distal end of theneedle and the distal end of the catheter into a blood vessel of thepatient; rotating the thumbwheel to advance the distal end of theguidewire out of the lumen of the needle into the blood vessel; movingthe catheter over the guidewire in the blood vessel; and removing theneedle and the guidewire from the catheter.
 2. The method according toclaim 1, wherein the catheter insertion device further comprises a bloodflashback chamber, further comprising observing blood in the flashbackchamber after inserting the needle and the catheter into the bloodvessel prior to rotating the thumbwheel.
 3. The method according toclaim 1, wherein an axis of rotation of the thumbwheel is perpendicularto the guidewire.
 4. The method according to claim 1, wherein thethumbwheel engages a friction wheel in the housing, and wherein rotatingthe thumbwheel rotates the friction wheel to advance the guidewire. 5.The method according to claim 1, wherein the needle is attached to aneedle carrier having a proximal end disposed in the housing.
 6. Themethod according to claim 5, wherein the catheter insertion devicefurther comprises an actuator mechanism including a biasing memberpositioned between a distal end of the housing and the needle carrier,and wherein activating the actuator mechanism releases the biasingmember.
 7. The method according to claim 6, wherein activating theactuator mechanism to release the biasing member simultaneously retractsthe distal end of the needle and the distal end of the guidewire intothe housing.
 8. The method according to claim 6, wherein activating theactuator mechanism comprises moving the thumbwheel laterally todisengage the needle carrier from a front plug in the housing.
 9. Themethod according to claim 1, wherein the guidewire has a proximalportion having a first diameter and a distal portion having a seconddiameter less than the first diameter, wherein the distal portion isformed into a coiled configuration at the distal end of the guidewire,and wherein advancing the distal end of the guidewire out of the lumenof the needle transitions the distal end of the guidewire from astraight configuration to the coiled configuration.
 10. The methodaccording to claim 1, wherein the distal end of the guidewire has acoiled configuration including a first coil in a first coil plane and asecond coil in a second coil plane different from the first coil plane,and wherein advancing the distal end of the guidewire out of the lumenof the needle transitions the distal end of the guidewire from astraight configuration to the coiled configuration.
 11. The methodaccording to claim 10, wherein advancing the distal end of the guidewireout of the lumen of the needle transitions the distal end of theguidewire to the coiled configuration without plastic deformation of theguidewire.
 12. The method according to claim 1, wherein: the distal endof the guidewire has a coiled configuration, comprising: a first coilextending from a straight portion of the guidewire, the first coil lyingsubstantially in a first coil plane; and a second coil extending fromthe first coil, the second coil lying substantially in a second coilplane parallel to the first coil plane, the second coil having adiameter less than or equal to a diameter of the first coil, wherein aline orthogonal to the first coil plane and the second coil plane issubstantially orthogonal to the straight portion of the guidewire, andadvancing the distal end of the guidewire out of the lumen of the needletransitions the distal end of the guidewire from a straightconfiguration to the coiled configuration.
 13. The method according toclaim 12, wherein a distal tip of the guidewire meets a bevel of theneedle in the fully withdrawn position, and wherein moving the catheterover the guidewire in the blood vessel comprises moving the distal endof the catheter over the distal end of the guidewire in the coiledconfiguration.
 14. The method according to claim 1, wherein the catheterhub is coupled to a distal end of the housing via an interference fit,wherein moving the catheter over the guidewire in the blood vesselcomprises uncoupling the catheter hub from the distal end of thehousing.
 15. The method according to claim 1, wherein the catheter hubis coupled to a member extending from a distal end of the housing,wherein moving the catheter over the guidewire in the blood vesselcomprises uncoupling the catheter hub from the member.